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Stavanger University Hospital Inflammatory Bowel Disease Trial (SUSI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Helse Stavanger HF
Sponsor:
Information provided by (Responsible Party):
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT01551563
First received: March 8, 2012
Last updated: August 26, 2016
Last verified: August 2016
  Purpose

The study aims at studying the outcomes of a protocol-based handling of newly diagnosed Inflammatory bowel disease ( IBD ) patients within a defined uptake area in Norway. It is a descriptive study and no hypothesis is predefined.

Cytokine studies, QoL and fatigue assessment will be included for hypothesis-generating purposes.


Condition
IBD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Management of Inflammatory Bowel Disease in the Stavanger Area - a Prospective Evaluation of Standardized Treatment Regimens on Disease Outcome With Focus on Mucosal Healing and Associations to Fatigue

Resource links provided by NLM:


Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • Clinical efficacy of IBD drug therapy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Endoscopic, clinical and biochemical response


Secondary Outcome Measures:
  • Fatigue in patients with coeliac disease - substudy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Fatigue at diagnosis and after one year of gluten free diet

  • Fatigue in IBD [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Fatigue at diagnosis and during follow-up


Biospecimen Retention:   Samples With DNA
Plasma and mucosal biopsies

Estimated Enrollment: 300
Study Start Date: April 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Detailed Description:
none considered needed
  Eligibility

Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All newly diagnosed IBD patients (Crohns and Ulcerative colitis) within Stavanger Univ Hospital catchment area
Criteria

Inclusion Criteria:

  • newly diagnosed IBD

Exclusion Criteria:

  • previous IBD with specific treatment within 10 year
  • inability to consent
  • inability to adhere to treatment protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551563

Contacts
Contact: tore grimstad tore.bjorn.grimstad@sus.no
Contact: lars aabakken larsaa@medisin.uio.no

Locations
Norway
SUS Recruiting
Stavanger, Norway
Contact: Tore B Grimstad, MD PhD    +47909 21 650      
Sponsors and Collaborators
Helse Stavanger HF
Investigators
Principal Investigator: lars Aabakken prof of medicine UIO
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01551563     History of Changes
Other Study ID Numbers: SUSI_1 
Study First Received: March 8, 2012
Last Updated: August 26, 2016
Health Authority: Norway: Regional Ethics Commitee
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on September 30, 2016